A Systematic Review of Implementation Research on Determinants and Strategies of Effective HIV Interventions for Men Who Have Sex with Men in the United States.

Men who have sex with men (MSM) are disproportionately affected by HIV, accounting for two-thirds of HIV cases in the United States despite representing ∼5% of the adult population. Delivery and use of existing and highly effective HIV prevention and treatment strategies remain suboptimal among MSM. To summarize the state of the science, we systematically review implementation determinants and strategies of HIV-related health interventions using implementation science frameworks. Research on implementation barriers has focused predominantly on characteristics of individual recipients (e.g., ethnicity, age, drug use) and less so on deliverers (e.g., nurses, physicians), with little focus on system-level factors. Similarly, most strategies target recipients to influence their uptake and adherence, rather than improving and supporting implementation systems. HIV implementation research is burgeoning; future research is needed to broaden the examination of barriers at the provider and system levels, as well as expand knowledge on how to match strategies to barriers-particularly to address stigma. Collaboration and coordination among federal, state, and local public health agencies; community-based organizations; health care providers; and scientists are important for successful implementation of HIV-related health innovations.

"Your Package Could Not Be Delivered": The State of Digital HIV Intervention Implementation in the US.

PURPOSE OF REVIEW: Despite continuous innovations and federal investment to create digital interventions addressing the HIV prevention and care continua, these interventions have not reached people in the U.S. at scale. This article reviews what is known about U.S. implementation of digital HIV interventions and presents a strategy to cross the research-to-practice chasm for these types of interventions. RECENT FINDINGS: We conducted a narrative review of U.S.-based original research on implementation of digital HIV interventions and identified few studies reporting on implementation determinants, strategies, processes, or outcomes, particularly outside the context of effectiveness trials. To supplement the literature, in 2023, we surveyed 47 investigators representing 64 unique interventions about their experiences with implementation after their research trials. Respondents placed high importance on intervention implementation, but major barriers included lack of funding and clear implementation models, technology costs, and difficulty identifying partners equipped to deliver digital interventions. They felt that responsibility for implementation should be shared between intervention developers, deliverers (e.g., clinics), and a government entity. If an implementation center were to exist, most respondents wanted to be available for guidance or technical assistance but largely wanted less involvement. Numerous evidence-based, effective digital interventions exist to address HIV prevention and care. However, they remain "on the shelf" absent a concrete and sustainable model for real-world dissemination and implementation. Based on our findings, we call for the creation of national implementation centers, analogous to those in other health systems, to facilitate digital HIV intervention delivery and accelerate progress toward ending the U.S. epidemic.

Improving Delivery and Use of HIV Pre-Exposure Prophylaxis in the US: A Systematic Review of Implementation Strategies and Adjunctive Interventions.

Implementation of pre-exposure prophylaxis (PrEP) to prevent HIV transmission is suboptimal in the United States. To date, the literature has focused on identifying determinants of PrEP use, with a lesser focus on developing and testing change methods to improve PrEP implementation. Moreover, the change methods available for improving the uptake and sustained use of PrEP have not been systematically categorized. To summarize the state of the literature, we conducted a systematic review of the implementation strategies used to improve PrEP implementation among delivery systems and providers, as well as the adjunctive interventions used to improve the uptake and persistent adherence to PrEP among patients. Between November 2020 and January 2021, we searched Ovid MEDLINE, PsycINFO, and Web of Science for peer reviewed articles. We identified 44 change methods (18 implementation strategies and 26 adjunctive interventions) across a variety of clinical and community-based service settings. We coded implementation strategies and adjunctive interventions in accordance with established taxonomies and reporting guidelines. Most studies focused on improving patient adherence to PrEP and most conducted pilot trials. Just over one-third of included studies demonstrated a positive effect on outcomes. In order to end the human immunodeficiency virus (HIV) epidemic in the U.S., future, large scale HIV prevention research is needed that develops and evaluates implementation strategies and adjunctive interventions for target populations disproportionately affected by HIV.

Determinants of Pre-exposure Prophylaxis (PrEP) Implementation in Transgender Populations: A Qualitative Scoping Review.

We conducted a scoping review of contextual factors impeding uptake and adherence to pre-exposure prophylaxis in transgender communities as an in-depth analysis of the transgender population within a previously published systematic review. Using a machine learning screening process, title and abstract screening, and full-text review, the initial systematic review identified 353 articles for analysis. These articles were peer-reviewed, implementation-related studies of PrEP in the U.S. published after 2000. Twenty-two articles were identified in this search as transgender related. An additional eleven articles were identified through citations of these twenty-two articles, resulting in thirty-three articles in the current analysis. These thirty-three articles were qualitatively coded in NVivo using adapted constructs from the Consolidated Framework for Implementation Research as individual codes. Codes were thematically assessed. We point to barriers of implementing PrEP, including lack of intentional dissemination efforts and patience assistance, structural factors, including sex work, racism, and access to gender affirming health care, and lack of provider training. Finally, over 60% of articles lumped cisgender men who have sex with men with trans women. Such articles included sub-samples of transgender individuals that were not representative. We point to areas of growth for the field in this regard.

RESUMEN: En este revisión de alcance, examinamos los factores contextuales que impiden la adopción y el cumplimiento de la profilaxis previa a la exposición en las comunidades transgénero. Este revisión sistemática se formó a partir de una revisión sistemática más grande. Utilizando un proceso de selección de aprendizaje automático, filtración de los titulus y examines, y revision del texto complete, el primer revisión sistemática identificó 353 artículos por el analisis. Estes artículos fueron estudios revisados por pares, relacionados con la implementación de la PrEP en los EE.UU. publicados despues de 2000. Veintidós artículos se identificaron en esta b?squeda como relacionados con personas transgénero. Se identificaron once artículos adicionales a través de citas de estos veintidós artículos, lo que resultó en treinta y tres artículos en el análisis actual. Estos treinta y tres artículos fueron codificados cualitativamente en NVivo utilizando construcciones adaptadas del Marco Consolidado para la Investigación de Implementación (CFIR) como códigos individuales. Los códigos fueron evaluados temáticamente. Señalamos las barreras de la implementación de la PrEP, como la falta de esfuerzos intencionales de difusión y asistencia al paciente, las barreras estructurales como el trabajo sexual, el racism, y el acceso a la salud de afirmación de género, y la falta del entrenamiento de los doctores. Finalmente, más de sesenta por ciento de los artículos tuvieron submuestras de personas transgénero que no eran representativas. Se?alamos áreas de crecimiento para el campo en este sentido.

The CAN-DO-IT Model: a Process for Developing and Refining Online Recruitment in HIV/AIDS and Sexual Health Research.

PURPOSE OF REVIEW: HIV/AIDS and sexual health research has increasingly relied on online recruitment in recent years. However, as potential online recruitment avenues (e.g., dating and sexual networking applications, websites, social media) have proliferated, navigating this process has become increasingly complex. This paper presents a practical model to guide researchers through online recruitment irrespective of platform. RECENT FINDINGS: The CAN-DO-IT model reflects 7 iterative steps based on work by the authors and other investigators: conceptualize scope of recruitment campaign, acquire necessary expertise, navigate online platforms, develop advertisements, optimize recruitment-to-enrollment workflow, implement advertising campaign, and track performance of campaigns and respond accordingly. Online recruitment can accelerate HIV/AIDS research, yet relatively limited guidance exists to facilitate this process across platforms. The CAN-DO-IT model presents one approach to demystify online recruitment and reduce enrollment barriers.

Landscape of HIV Implementation Research Funded by the National Institutes of Health: A Mapping Review of Project Abstracts.

In 2019, the requisite biomedical and behavioral interventions to eliminate new HIV infections exist. "Ending the HIV Epidemic" now becomes primarily a challenge of will and implementation. This review maps the extent to which implementation research (IR) has been integrated into HIV research by reviewing the recent funding portfolio of the NIH. We searched NIH RePORTER for HIV and IR-related research projects funded from January 2013 to March 2018. The 4629 unique studies identified were screened using machine learning and manual methods. 216 abstracts met the eligibility criteria of HIV and IR. Key study characteristics were then abstracted. NIH currently funds HIV studies that are either formally IR (n = 109) or preparatory for IR (n = 107). Few (13%) projects mentioned a guiding implementation model, theory, or framework, and only 56% of all studies explicitly mentioned measuring an implementation outcome. Considering the study aims along an IR continuum, 18 (8%) studies examined barriers and facilitators, 43 (20%) developed implementation strategies, 46 (21%) piloted strategies, 73 (34%) tested a single strategy, and 35 (16%) compared strategies. A higher proportion of formal IR projects involved established interventions (e.g., integrated services) compared to newer interventions (e.g., pre-exposure prophylaxis). Prioritizing HIV-related IR in NIH and other federal funding opportunity announcements and expanded training in implementation science could have a substantial impact on ending the HIV pandemic. This review serves as a baseline by which to compare funding patterns and the sophistication of IR in HIV research over time.

Condom-Associated Erectile Function, But Not Other Domains of Sexual Functioning, Predicts Condomless Insertive Anal Sex Among Young Men Who Have Sex with Men.

Condoms effectively prevent against HIV, especially when used in conjunction with biomedical strategies such as PrEP and viral suppression. However, consistent use of condoms in the real world has been a continual health promotion challenge, even among populations at highest risk, such as young men who have sex with men (YMSM). Inconsistent condom use may be related to poor sexual functioning, but limited research exists. The analytic sample comprised 688 racially diverse YMSM aged 16-29 (M = 22.9 years) living in Chicago, IL (19.2% living with HIV). Using multivariable logistic regression, we examined longitudinal associations between condom-associated sexual functioning (erectile function, orgasm satisfaction, global satisfaction, and anal discomfort) and condomless insertive anal sex (CIAS) and condomless receptive anal sex (CRAS) 6 months later. CIAS at Time 2 was associated with condom-associated erectile function at the bivariate and multivariable levels, even after controlling for CIAS at Time 1 (p < .05). Condom-associated erectile function, orgasm satisfaction, and global satisfaction predicted Time 2 CRAS in bivariate models, but none remained significant in the multivariable models. Age, having had a serious partner in the past 6 months, and HIV/PrEP status at Time 2 were significant predictors of CIAS/CRAS in some but not all models. Future interventions to improve consistent condom use should specifically highlight information and skills on how to use condoms within real-world contexts rather than from a clinical perspective. Our results also support the importance of biomedical strategies for those who have continued problems with sexual functioning when using condoms.

Using Intervention Mapping to Developmentally Adapt an Online HIV Risk Reduction Program for Adolescent Men Who Have Sex with Men.

Adolescent men who have sex with men (AMSM) experience a dramatic health disparity in HIV, accounting for over 80% of new diagnoses among youth. Current evidence-based HIV prevention programs, however, focus primarily on adults and heterosexual youth, thereby missing the unique experiences and socio-environmental contexts of AMSM aged 13-18. To address these gaps, we used the Intervention Mapping (IM) protocol to developmentally adapt an existing evidence-based online HIV risk reduction program (i.e., Keep it Up!/KIU!), originally designed for young adult MSM aged 18-29, into a new intervention called SMART Squad. Using a hybrid of IM creation and adaptation tasks, we specified three behavioral outcomes and identified corresponding performance objectives for SMART Squad based on the original goals of KIU!. We constructed matrices of change objectives using determinants from the Information-Motivation-Behavioral Skills model, modifying them for the younger population with additional theoretical and empirical evidence and expert review. SMART Squad activities were operationalized from theory-based behavior change methods matched to the change objectives and guided by program themes, components, and scope imported from KIU!. The final SMART Squad intervention comprises 6 episodes/modules delivered in 2 sessions plus 2 booster episodes occurring 1 and 3 months after the main program. It is currently being evaluated nationally as part of a stepped-care package of 3 programs, in which the receipt and sequencing of interventions is tailored to individual AMSM development and needs. Despite substantial changes to KIU!, IM was a useful method for retaining the hypothesized essential elements of the eHealth HIV risk reduction program. Challenges and recommendations for future researchers and practitioners are discussed.

Exploring anal self-examination as a screening tool for women at risk for anal cancer: awareness, interest, and barriers to behavioral uptake.

PURPOSE: Anal cancer is the second most common human-papillomavirus-related cancer in women, with women also at an elevated risk of incidence relative to men. Anal self-examination (ASE) is an efficient way for women to screen between provider visits for potential anal masses. While studied in male populations, no research has explored women's awareness of the self-test. METHODS: In response, 345 women recruited from online advertisements and listservs were surveyed to assess their experiences using health care, history of Pap smears, knowledge of anal cancer, awareness and attitudes surrounding ASEs, and potential educational modalities to promote ASE enactment. RESULTS: Results indicated the sample failed two key anal cancer knowledge tests (receiving a 68%/100% for risk factors and 61%/100% for signs/symptoms), and only 2.3% of participants had ever heard of ASEs before the survey. Most thought ASEs would be somewhat helpful as a screening tool, but little interest was shown towards future performance. Analyses revealed this disinterest was due to lack of knowledge, perceived discomfort with performing ASEs, and perceived irrelevance of ASEs. CONCLUSIONS: Future interventions should push for a stronger role of providers (e.g., gynecologists) in anal health, education, and screening. Additionally, campaigns should be crafted to promote the ASE as an easy, at-home screening tool that could trigger an early warning for anal disease.

Design Considerations for Implementing eHealth Behavioral Interventions for HIV Prevention in Evolving Sociotechnical Landscapes.

PURPOSE OF REVIEW: Despite tremendous potential for public health impact and continued investments in development and evaluation, it is rare for eHealth behavioral interventions to be implemented broadly in practice. Intervention developers may not be planning for implementation when designing technology-enabled interventions, thus creating greater challenges for real-world deployment following a research trial. To facilitate faster translation to practice, we aimed to provide researchers and developers with an implementation-focused approach and set of design considerations as they develop new eHealth programs. RECENT FINDINGS: Using the Accelerated Creation-to-Sustainment model as a lens, we examined challenges and successes experienced during the development and evaluation of four diverse eHealth HIV prevention programs for young men who have sex with men: Keep It Up!, Harnessing Online Peer Education, Guy2Guy, and HealthMindr. HIV is useful for studying eHealth implementation because of the substantial proliferation of diverse eHealth interventions with strong evidence of reach and efficacy and the responsiveness to rapid and radical disruptions in the field. Rather than locked-down products to be disseminated, eHealth interventions are complex sociotechnical systems that require continual optimization, vigilance to monitor and troubleshoot technological issues, and decision rules to refresh content and functionality while maintaining fidelity to core intervention principles. Platform choice and sociotechnical relationships (among end users, implementers, and the technology) heavily influence implementation needs and challenges. We present a checklist of critical implementation questions to address during intervention development. In the absence of a clear path forward for eHealth implementation, deliberate design of an eHealth intervention's service and technological components in tandem with their implementation plans is critical to mitigating barriers to widespread use. The design considerations presented can be used by developers, evaluators, reviewers, and funders to prioritize the pragmatic scalability of eHealth interventions in research.

Stigma on the Streets, Dissatisfaction in the Sheets: Is Minority Stress Associated with Decreased Sexual Functioning Among Young Men Who Have Sex with Men?

INTRODUCTION: Sexual function and satisfaction are understudied aspects of adolescent and young adult sexual wellbeing, and even less is known about sexual minority youth who are vulnerable to unique lesbian, gay, bisexual, and transgender (LGBT)-related stigma. AIM: We aimed to describe sexual functioning (sexual interest, erectile function, orgasm satisfaction, global satisfaction with one's sex life, and anal discomfort) and examine its associations with demographics, sexual and relationship behavior, and minority stressors (internalized stigma, victimization, microaggressions, and perceived LGBT acceptance within residential neighborhood) among a cohort of young men who have sex with men (YMSM) aged 16-29. METHODS: Data for this cross-sectional analysis came from an ongoing longitudinal study of HIV and substance use among YMSM (analytic N = 678). We conducted univariate and bivariate analyses and multivariable linear regression, controlling for age, race/ethnicity, and sexual orientation as well as sexual and relationship characteristics that were significant at the bivariate level. MAIN OUTCOME MEASURE: We assessed sexual functioning in the previous 30 days using the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction Measures Brief Profile for Males. RESULTS: YMSM in our sample reported high levels of sexual functioning that were significantly greater than an adult clinical reference population. However, 13.9% of the sample reported having any difficulty with erections, 6.9% reported having less than "good" satisfaction with orgasms, 20.0% reported being "somewhat" or less satisfied with their sex lives, and 9.1% reported experiencing problems during receptive anal sex at least "sometimes." Most associations between minority stressors and sexual functioning domains that were significant at the bivariate level attenuated to non-significance in multivariable analyses. Internalized stigma remained negatively associated with global satisfaction, whereas perceived neighborhood acceptance remained positively associated with orgasm satisfaction. Being sexually active was significantly associated with increased sexual interest and orgasm satisfaction. Having had a recent serious partner was significantly associated with sexual interest and global satisfaction. Negative effects were found for having had casual partners and being HIV positive. CLINICAL IMPLICATIONS: Although most YMSM have high sexual functioning, a minority report problems and dissatisfaction that may warrant intervention. STRENGTHS & LIMITATIONS: Our study was limited by its cross-sectional design, measurement limitations, and generalizability to other populations, but it is one of the first to examine sexual functioning among YMSM, using a large, diverse community sample. CONCLUSION: Public health research and practice must continue to combat LGBT stigma and include sexual functioning as integral to healthy sexuality. Li DH, Remble TA, Macapagal K, et al. Stigma on the Streets, Dissatisfaction in the Sheets: Is Minority Stress Associated with Decreased Sexual Functioning Among Young Men Who Have Sex with Men? J Sex Med 2019;16:267-277.

Comparing the Healthcare Utilization and Engagement in a Sample of Transgender and Cisgender Bisexual+ Persons.

People who identify as non-monosexual and transgender experience disparities in engagement with healthcare services relative to monosexual and cisgender persons, respectively. However, little is known about the healthcare utilization of those with intersecting sexual and gender minority identities. We explored the knowledge, attitudes, and health motivation of non-monosexually identified transgender participants regarding preventive care and access to sexual healthcare services. We surveyed 87 ciswomen, 34 transwomen, and 27 transmen, all of whom identified as bisexual, pansexual, or queer (bi+). We assessed their access to health care, health outcome experiences, confidence with talking about anogenital topics, proactivity toward their health, comfort with healthcare providers, and knowledge about HPV and examined differences across groups. The data indicated that bi+ transmen and transwomen were more likely to be uninsured or on a government-sponsored insurance plan relative to bi+ ciswomen. Only a minority of transmen and transwomen had seen an obstetrician/gynecologist compared with ciswomen. Transmen were less likely to have received a pelvic examination or cervical Pap smear in their lifetime. Transgender participants had significantly less correct knowledge about HPV relative to ciswomen. Finally, relative to ciswomen, transgender participants reported lower comfort talking with health providers. Our findings suggest that bi+ transmen and transwomen access care less than bi+ ciswomen and have less health knowledge and comfort with their providers. Implications for intervention include encouraging transgender individuals to seek routine screenings, reducing structural barriers to care based on medical coverage, and improving patient-provider competencies around bi+ and transgender health needs.

The Longitudinal Associations Between Outness and Health Outcomes Among Gay/Lesbian Versus Bisexual Emerging Adults.

Sexual minorities are at increased risk for substance use and mental health problems. Although previous studies have examined the associations between outness and health outcomes, few have used longitudinal designs or examined differences across subgroups of sexual minorities. To address these gaps, the current study examined sexual orientation and gender as moderators of the longitudinal associations between outness and substance use (cigarettes, marijuana, illicit drugs, and alcohol) and mental health (depression and anxiety). Data were from a sample of 169 sexual minority emerging adults (98 women and 71 men) who provided self-report data at four times over 3.5 years. Results indicated that sexual orientation moderated the within-person associations between outness and changes in health. For bisexual individuals, being more out was associated with increases in marijuana use, illicit drug use, and depression. In contrast, for gay/lesbian individuals, being more out was associated with decreases in illicit drug use and it was not significantly associated with changes in marijuana use or depression. Additionally, outness was not significantly associated with changes in cigarette use, alcohol use, or anxiety for gay/lesbian or bisexual individuals, and gender did not moderate any of the associations. In sum, being more open about one's sexual orientation had negative consequences for bisexual individuals but not for gay/lesbian individuals. Professionals who work with sexual minorities need to be aware of the potential risks of being open about one's sexual orientation for bisexual individuals. Interventions are needed to facilitate disclosure decisions and to promote the health of sexual minorities.

Adjunctive interventions: change methods directed at recipients that support uptake and use of health innovations.

BACKGROUND: Implementation science groups change methods into two categories: (1) clinical, behavioral, or biomedical intervention targeting recipient's health outcomes and (2) implementation strategies targeting the delivery system. Differentiating interventions from strategies based on their intended functions is critical to accurately attributing their effects to health or implementation outcomes. However, in coordinating 200+ HIV implementation research projects and conducting systematic reviews, we identified change methods that had characteristics of both interventions and strategies that were inconsistently categorized. To alleviate confusion and improve change method specification, we propose that implementation science should adopt an extant but rarely used term-adjunctive interventions-to classify change methods that are distinct from the common intervention/strategy taxonomy. MAIN TEXT: Adjunctive interventions as change methods that target recipients (e.g., patients, participants) of a health intervention but are designed to increase recipients' motivation, self-efficacy, or capacity for initiating, adhering to, complying with, or engaging with the health intervention over time. In two of our published reviews on implementation of HIV interventions, 25 out of 45 coded change methods fell into this gray area between strategy and intervention. We also noted instances in which the same change method was labelled as the intervention ("the thing"), as an adjunctive intervention, or an implementation strategy in different studies-further muddying the waters. Adjunctive interventions are distinguished from other change methods by their intended targets, desired outcomes, and theory of action and causal processes. Whereas health interventions target recipients and have a direct, causal effect on the health outcome, adjunctive interventions enhance recipients' attitudes and behaviors to engage with the intervention and have an indirect causal link to the health outcome via increasing the probability of recipients' utilization and adherence to the intervention. Adjunctive interventions are incapable of directly producing the health outcome and will themselves require implementation strategies to effectively impact sustained uptake, utilization, and adherence. Case examples, logic modeling, and considerations (e.g., relationship to consumer engagement strategies) for adjunctive intervention research are provided. CONCLUSION: Conceptualizing adjunctive interventions as a separate type of change method will advance implementation research by improving tests of effectiveness, and the specification of mechanisms and outcomes.

The "D&I Bridge": introducing a teaching tool to define the D, the I, and the why.

Interest in learning dissemination and implementation (D&I) science is at an all-time high. As founding faculty and fellows of a new center focused on D&I science, we have found that non-specialist researchers and newcomers to D&I science often express confusion around the difference between the D and the I. Relatedly, they struggle to identify what their specific D&I projects target to impact public health within the amorphous "black box" that is the singular, loosely defined "research-to-practice gap." To improve conceptual clarity and enhance engagement with D&I science, we developed a graphic-the D&I Bridge-and an accompanying glossary of terms to use as a teaching and framing tool. The D&I Bridge depicts D&I science as bridging what we know from public health knowledge to what we do in public health practice with intention and equity, and it spans over four distinct, inter-related gaps: the public health supply gap, the public health demand gap, the methodological/scientific gap, and the expertise capacity gap. The public health supply gap is addressed by implementation strategies, whereas the public health demand gap is addressed by dissemination strategies. The methodological/scientific gap is addressed by producing generalizable knowledge about D&I, and the expertise capacity gap is addressed by developing the multi-disciplinary workforce needed to advance D&I. Initial practice feedback about the D&I Bridge has been positive, and this conceptualization of D&I science has helped inform our center's D&I training, D&I project consultations, and strategic planning. We believe the D&I Bridge provides a useful heuristic for helping non-specialists understand the differential scopes of various D&I science projects as well as specific gaps that may be addressed by D&I methods.

Establishing evidence criteria for implementation strategies in the US: a Delphi study for HIV services.

BACKGROUND: There are no criteria specifically for evaluating the quality of implementation research and recommending implementation strategies likely to have impact to practitioners. We describe the development and application of the Best Practices Tool, a set of criteria to evaluate the evidence supporting HIV-specific implementation strategies. METHODS: We developed the Best Practices Tool from 2022-2023 in three phases. (1) We developed a draft tool and criteria based on a literature review and key informant interviews. We purposively selected and recruited by email interview participants representing a mix of expertise in HIV service delivery, quality improvement, and implementation science. (2) The tool was then informed and revised through two e-Delphi rounds using a survey delivered online through Qualtrics. The first and second round Delphi surveys consisted of 71 and 52 open and close-ended questions, respectively, asking participants to evaluate, confirm, and make suggestions on different aspects of the rubric. After each survey round, data were analyzed and synthesized as appropriate; and the tool and criteria were revised. (3) We then applied the tool to a set of research studies assessing implementation strategies designed to promote the adoption and uptake of evidence-based HIV interventions to assess reliable application of the tool and criteria. RESULTS: Our initial literature review yielded existing tools for evaluating intervention-level evidence. For a strategy-level tool, additions emerged from interviews, for example, a need to consider the context and specification of strategies. Revisions were made after both Delphi rounds resulting in the confirmation of five evaluation domains - research design, implementation outcomes, limitations and rigor, strategy specification, and equity - and four evidence levels - best, promising, more evidence needed, and harmful. For most domains, criteria were specified at each evidence level. After an initial pilot round to develop an application process and provide training, we achieved 98% reliability when applying the criteria to 18 implementation strategies. CONCLUSIONS: We developed a tool to evaluate the evidence supporting implementation strategies for HIV services. Although specific to HIV in the US, this tool is adaptable for evaluating strategies in other health areas.

Acceptability of 'Humpr': An Online Tool to Educate Adolescent Sexual Minority Males About Sexual Networking Applications.

We examined the acceptability of Humpr - an interactive, online tool developed to educate adolescent sexual minority males (ASMM) about how to safely navigate sexual networking applications (SNA). We developed Humpr as part of a larger HIV intervention trial in the U.S. In Humpr, 218 ASMM aged 14-20 (Mage = 17.18) created a mock dating profile, explored simulated user profiles, learned health-related information (e.g. slang indicating HIV/STI risks and/or drug use intentions), and then gave feedback regarding acceptability of the tool. Results showed that Humpr was very well-received, with 94% overall approval rates. Reasons for liking Humpr were evenly split between liking it for educational and entertaining reasons. Participants praised Humpr for its realistic design and interactive interface that allowed them to engage and connect with the tool. The majority (61%) had used SNAs in the past, but many still reported learning something new from Humpr. Participants also appreciated the acknowledgment of SNA use in ASMM and how the education was implemented in an open and judgment-free way. Topics learned from Humpr included how to be safe on SNAs and warning signs for HIV/STI risks. Suggested areas of improvement included having an opt-out option for those who do not wish to participate for any reason (e.g. discomfort) and additional educational content (e.g. consequences of being a minor on SNAs). Taken together, the findings offer preliminary evidence for the potential educational benefits of digital tools like Humpr for ASMM with and without prior SNA exposure.

Keep It Up! 3.0: Study protocol for a type III hybrid implementation-effectiveness cluster-randomized trial.

BACKGROUND: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims. METHODS: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes. DISCUSSION: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation.

Supporting the Growth of Domestic HIV Implementation Research in the United States Through Coordination, Consultation, and Collaboration: How We Got Here and Where We Are Headed.

BACKGROUND: The Ending the HIV Epidemic (EHE) initiative sets a goal to virtually eliminate new HIV infections in the United States by 2030. The plan is predicated on the fact that tools exist for diagnosis, prevention, and treatment, and the current scientific challenge is how to implement them effectively and with equity. Implementation research (IR) can help identify strategies that support effective implementation of HIV services. SETTING: NIH funded the Implementation Science Coordination Initiative (ISCI) to support rigorous and actionable IR by providing technical assistance to NIH-funded projects and supporting local implementation knowledge becoming generalizable knowledge. METHODS: We describe the formation of ISCI, the services it provided to the HIV field, and data it collected from 147 NIH-funded studies. We also provide an overview of this supplement issue as a dissemination strategy for HIV IR. CONCLUSION: Our ability to reach EHE 2030 goals is strengthened by the knowledge compiled in this supplement, the services of ISCI and connected hubs, and a myriad of investigators and implementation partners collaborating to better understand what is needed to effectively implement the many evidence-based HIV interventions at our disposal.

Profile of the Portfolio of NIH-Funded HIV Implementation Research Projects to Inform Ending the HIV Epidemic Strategies.

BACKGROUND: The US government created an initiative to end the HIV epidemic in the United States by the year 2030 (EHE). This multiagency initiative was structured around four pillars: Prevent, Diagnose, Treat, and Respond to improve HIV programs, resources, and service delivery infrastructure. In support of its research mission, the National Institutes of Health (NIH) has funded implementation research (IR) projects by addressing the four pillars and encouraging investigators to collaborate with local partners and Health and Human Services (HHS) grantees in 57 priority jurisdictions. METHODS: This paper analyzed data from the NIH funded CFAR/ARC supplement projects from 2019 to 2021. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework was used to characterize projects by stage of implementation. RESULTS: The Prevent pillar was most frequently studied, with Pre-Exposure Prophylaxis (PrEP) being the most studied intervention. The most common partners were health departments, community-based organizations (CBOs), and Federally Qualified Health Centers (FQHCs). The Consolidated Framework for Implementation Research (CFIR) framework was the most utilized to investigate implementation determinants, followed by the RE-AIM framework and Proctor model to assess implementation outcomes. CONCLUSION: Monitoring the projects resulting from NIH investments is fundamental to understanding the response to EHE, and achieving these results requires systematic and continuous effort that can support the generalizable implementation knowledge emerging from individual studies. There are some remaining gaps in the project portfolio, including geographical coverage, range of implementation outcomes being measured, and interventions still requiring further research to ensure equitable scale-up of evidence based interventions and achieve EHE goals.